# FDA 483 - UF Reproductive Medicine at Springhill - June 06, 2019

Source: https://www.keypedia.com/records/483/uf-reproductive-medicine-at-springhill/c9046795-23ef-4ddc-871a-b5498b8d1bca

> FDA 483 for UF Reproductive Medicine at Springhill on June 06, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UF Reproductive Medicine at Springhill
- Inspection Date: 2019-06-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of UF Reproductive Medicine at Springhill in Gainesville, FL, a reproductive tissue establishment, identified significant deficiencies related to the processing and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included inadequate labeling of HCT/Ps for which donor eligibility was not performed, specifically regarding warning statements for communicable disease risks. Additionally, the firm's procedures were found to be insufficient to ensure compliance with donor eligibility requirements, particularly concerning the use of biohazard legends for ineligible directed reproductive donors.

## Related Officers

- [Investigator](https://www.keypedia.com/people/valerie-j-grecek-trinh/d8b9c0fc-0935-4e34-88cf-a9fc4f7805a5)

Company: https://www.keypedia.com/companies/uf-reproductive-medicine-at-springhill/c5a462e7-cc93-4ddc-a8a8-b0ef73ca28e0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6